A Non-interventional Implementation Study to Evaluate Treatment With Inclisiran (Leqvio®) and Other Lipid Lowering Treatments in a Real-world Setting

Date of first Atherosclerotic Cardiovascular Disease (ASCVD) diagnosis is collected

Number of patients with cardiovascular events is collected

Number of participants with concomitant medication in the previous 12 months is collected

Number of apheresis treatments in the previous 12 months is collected

Lipid lowering therapy used in the previous 12 months is collected

Number of lipid apheresis conducted on Apheresis plus Inclisiran cohort is collected

Low Density Lipoprotein cholesterol (LDL-C) is collected

Number of In- and outpatient visits is collected

Number of examinations is collected

Number and types of lipid lowering treatments are collected

Number of consultations beside regular visits are collected

Percentage of patients progressing to lipoprotein apheresis after initial Inclisiran therapy over time is collected for the Inclisiran Cohort.

Percentage of days covered (PDC) by at least one lipid lowering treatment (LLT) is collected

Percentage of patients with a Percentage of days covered (PDC) ≥ 80% months is collected

Time to discontinuation of Inclisiran/ any lipid lowering treatment (LLT) is collected

Percentage of patients who discontinue Inclisiran/ any lipid lowering treatment (LLT) is collected

Change in Low denisty lipoprotein cholesterine (LDL-C) compared to baseline is measured

Changes in total cholesterol (TC), High Denisty lipoprotein C (HDL-C) and non-HDL-C compared to Baseline is measured

Change in c-reactive protein compared to baseline is measured

Changes in triglycerides and Lipoprotein (a) (LP(a)) compared to baseline are measured

Change in high-sensitivity C-reactive protein (hs-CRP) compared to Baseline is measured

Change in Creatinin compared to baseline is measured

Change in Glycated hemoglobin (HbA1c) compared to baseline is measured

Change in Estimated Glomerular Filtration Rate (eGFR) compared to baseline is measured

Proportion of patients achieving prespecified LDL-C targets based on 2019 ESC/EAS guideline for the management of dyslipidemia is collected

Percentage of patients achieving ≥50% LDL-C reduction over time is collected

The SMART Risk Score is a tool to estimate 10-year risk for recurrent vascular events in patients with manifest cardiovascular disease. SMART Risk Score ranges from 0 - 100 %, where higher values indicate higher cv risk.

Proportion of patients with the following treatment modifications, is collected:

• dose changes
• switching of lipid lowering treatment
• initiation of lipid apheresis for LDL-C

Each individual item of the WHOQOL-BREF is scored from 1 to 5 on a response scale, which is stipulated as a five-point ordinal scale. The scores are then transformed linearly to a 0-100-scale. Higher numbers indicate better QoL.

Treatment Satisfaction Questionnaire for Medication-9 items (TSQM-9) domain scores range from 0 -100, with higher scores representing higher satisfaction on that domain.

Questionnaire from the German "Nationale Verzehrstudie II -Was esse ich" is used. No score is used for the interpretation. Questions about nutrition and activities are interpreted separately and compared over time.

Percentage of Adverse Events (AEs) and Serious Adverse Events (SAEs) is collected

Percentage of Adverse Events and Serious Adverse Events leading to discontinuation of therapy is collected

Changes in the rate of lipid apheresis over time after Inclisiran initiation compared to the period 12 months pre-Baseline is collected.

Changes in high-sensitive C-reactive protein (hsCRP) are measured in labs. Values are interpresetd as;

• less or 1.0 mg/l is normal 1.01 - 3.00 slightly high more than 3.0 mg/l is significantly elevated

Apheresis plus Inclisiran Cohort: Changes in Parathyroid hormone (PTH)